Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. (25th October 2022)

• Record Type: Journal Article
• Authors: Goodney, Philip; Mao, Jialin; Columbo, Jesse; Suckow, Bjoern; Schermerhorn, Marc; Malas, Mahmoud; Brooke, Benjamin; Hoel, Andrew; Scali, Salvatore; Arya, Shipra; Spangler, Emily; Alabi, Olamide; Beck, Adam; Gladders, Barbara; Moore, Kayla; Zheng, Xinyan; Eldrup-Jorgensen, Jens; Sedrakyan, Art
• Other Names: author non-byline.; Giles Kristina author non-byline.; Beach Jocelyn author non-byline.; Clouse W Darrin author non-byline.; Stone David author non-byline.; Randall M D author non-byline.; Mansukhani Neel author non-byline.; Wang Grace author non-byline.; Woo Karen author non-byline.; Mureebe Leila author non-byline.; Dalsing Michael author non-byline.; Maijub John author non-byline.; Chaar Cassius author non-byline.; Duwayri Yazan author non-byline.; Bertges Daniel author non-byline.; Mena-Hurtado Carlos author non-byline.; Smolderen Kim author non-byline.; Berman Scott author non-byline.; Osborne Nicholas author non-byline.; Henke Peter author non-byline.; Cronenwett Jack author non-byline.
• Is Part Of: BMJ. Volume 379(2022)
• Publication Date: 2022-10-25
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2022-071452
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract: Objective: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. Design: Observational surveillance study. Setting: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). Participants: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. Main outcome measures: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. Results: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. Conclusions: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.